For assessing the inner morphology of the uterine cavity, or the patency of the fallopian tubes, physicians can utilize a variety of fluids and media for providing visualization during ultrasound and radiographic procedures. In some situations, the visualization quality of the ultrasonic imaging can be enhanced with additional echogenic constituents within the fluid media such as particles, air bubbles, CO2 bubbles, and other contrasting materials that provide additional reflection and echogenicity for ultrasound. For uterine cavities, physicians evaluate the inner morphology of the cavity for the presence of disease while observing surrounding tissues and structures.
Fallopian tubes are potential spaces unless an intra-tubal insert is in situ, or in the presence of fallopian tube disease. These disease states can distort, occlude, or distend the fallopian tube walls in cases such as hydrosalphinges, inflammation, or when the culmination of bodily materials build up as deposits or detritus, or when remnants of previous ectopic pregnancies are present in the fallopian tube lumens. For assessing the inner morphology of the fallopian tubes, the patency of fallopian tubes, or the presence of tubal inserts, sufficient intra-uterine pressure needs to be generated to push or force the flow of media through the tubes. Literature indicates that the required amount of fluid pressure delivered at the endocervix through transcervical hysterosalpingography catheters to allow the flow of media through the fallopian tubes is on average 70 mmHg and pressure values using CO2 or fluid media have ranged higher and lower than that average value.
A prior version for enhancing image quality utilizes the addition of a foaming agent or foam within a catheter system with subsequent injection into the uterine cavity. The foam is prepared by the operator through agitation of the foam and typically a fluid media such as saline. A catheter is introduced into the uterine cavity and a seal is created at the internal cervical os by a balloon or at the exocervix through the use of an occluding member or stopper at the cervical opening. The goal of these occluding devices is to maintain a seal within the uterine cavity so that sufficient pressure can be created through the injection of the foam/fluid media mixture to fill and distend the uterine cavity for inner surface examination. With additional pressure, up to the average 70 mmHg as reported in literature, the foam/fluid media mixture can infiltrate the fallopian tubes. Upon complete infiltration through the fallopian tubes and into the peritoneal cavity, the physician can make the assessment that the fallopian tubes are patent, or open, as evidenced by the spillage of fluid through the tubal lumen and into the peritoneal cavity or by visualization of bubbles traversing the fallopian tubes. This information can be useful for counseling women and couples for infertility and also for post-tubal insert implantation for permanent contraception. As an example, a foam agent can trap air particles or bubbles within a media prior to injection into the body. The foam mixture can be created manually by the operator by agitating a gel media with saline with two inter-connected syringes to create bubbles. Once turned to a foam consistency, the mixture is instilled into the body during sonographic procedures.
As an alternative, the art discloses the benefits of small sized gas bubbles for enhanced visualization of the fallopian tubes as well as the use of various gels and higher viscosity fluids for reducing the leakage of media out of the cervical canal during diagnostic uterine cavity procedures. The small sized gas bubbles, as one example, create greater sonographic reflections or echogenicity of the fluid during ultrasound diagnostic procedures.
Several uses of multiple syringe mechanisms for introducing two contrasting materials into a bodily cavity are known. For example, a first and second pump can supply sterile saline and micro-filtered air into the body for improved visualization during diagnostic procedures. The second pump filled with air is used to inject air into the saline and supplying the saline and air mixture into the body.
The use of two syringes: one syringe filled with a media comprised of small sized or micro-bubbles, and the other syringe filled with saline for simultaneous injection into the body is also known. The mixture is designed for improved visualization during sonographic procedures and evaluation of fallopian tube patency.
Yet another known method for enhancing visualization with ultrasound during fallopian tube diagnostic procedures uses a double barrel syringe for the injection of air and saline into the uterine cavity. When loading the system with saline, a second syringe barrel is drawing up room air. Once connected to a catheter and upon the depression of a plunger on the double barrel syringe, saline and air is combined at the base of the syringe through a y-fitting and then travels through the length of the catheter and into the uterine cavity. As the air bubbles combine with saline at the y-fitting, the coalescence of the bubbles occurs rapidly and echogenicity degrades as the air bubbles and saline traverse the length of the catheter. Importantly, the instructions for use in these double barrel catheter systems note that the bubbles employed in the media can create artifact while visualizing the uterine cavity since the bubbles may obscure anatomical features inside or on the inner cavity wall of the uterus.
In regards to bubble creation and venturi effect mechanisms, a micro bubble generating mechanism for shower heads is known. Other examples include nebulizing catheter systems for use in the pulmonary organs, and microparticulate introduction within perfluorocarbon liquid medications. A catheter with an aeration element within the distal end of the catheter for improving visualization within the uterine cavity and fallopian tubes is also known. Other applications depict a venturi mechanism attached to the proximal luer connector on the proximal portion of a catheter for the simultaneous infusion of air and saline within the uterine cavity.
A deflecting surface adjacent to the distal opening of an elongated catheter for directing a member or a fluid is known. As is an internal mandrel for selectively straightening a curved catheter for insertion into the uterine cavity. As another representative example of related art, a steerable catheter is known that provides articulation of the distal end.
Echogenicity can be altered (e.g., increased) with micro-bubbles or smaller bubbles. Ultrasound artifact by the presence of larger, obscuring air bubbles, can be reduced with the reduction of larger bubbles since the presence of the larger bubbles have been reported to obscure polyps or inner cavitary lesions.